N/A N=106 Randomized Single-blind Supportive Care

Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers

Myopia · Astigmatism · Hyperopia · Refractive Error

Bottom Line

View on ClinicalTrials.gov: NCT01912781 ↗

Enrolled (actual)

106

Serious AEs

0.0%

Results posted

Jun 2015

Primary outcome: Primary: Percentage of Subjects With Visibly Clean Lenses — 42.0; 57.1; 29.0; 42.9 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FID 120947A contact lens disinfecting solution (Device); Boston Simplus multi-action solution (Device); Gas permeable contact lenses (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Alcon Research
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Visibly Clean Lenses	42.0; 57.1; 29.0; 42.9; 29.0; 42.9	—
PRIMARY Percentage of Subjects With Crystalline Deposits by Type	90.0; 80.0; 0.0; 20.0; 10.0; 0.0	—
PRIMARY Percentage of Subjects With Film Deposits by Type	80.0; 66.7; 7.5; 26.7; 12.5; 6.7	—
PRIMARY Average Residual Lens Lysozyme	0.2; 0.2	—
PRIMARY Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change	0.0; 0.0; 2.9; 0.0; 92.8; 94.3	—
PRIMARY Average Lens Wear Time	12.3; 13.3; 12.5; 12.7; 11.8; 13.3	—
PRIMARY Number of Unscheduled Lens Replacements by Reason	3; 1; 0; 1; 1; 0	—
PRIMARY Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."	30.4; 68.6; 52.2; 28.6; 7.2; 0.0	—
PRIMARY Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."	37.7; 48.6; 40.6; 45.7; 2.9; 0.0	—
PRIMARY Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."	23.2; 48.6; 50.7; 40.0; 20.3; 8.6	—
PRIMARY Crystalline Deposit Area Covered	18.0; 19.0; 13.6; 16.7; 11.9; 7.0	—
PRIMARY Film Deposit Area Covered	23.8; 22.7; 26.2; 28.4; 26.4; 24.0	—

Summary

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in gas permeable lens wearers.

Eligibility Criteria

Inclusion Criteria

Normal eyes (other than correction for visual acuity);
Successful history of gas permeable contact lens wear in both eyes in one of two brands: Boston XO or Boston II;
Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
History of intolerance or hypersensitivity to any component of the investigational products;
Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
Moderate, severe, abnormal, or other ocular findings;
Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
Ocular surgery within the last 12 months;
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01912781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.